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Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

Recruitingn/aAges 18 Years - anyAllUniversity of Pennsylvania
NCT07132788 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients with pulmonary arterial hypertension (PAH) are at increased risk of muscle loss and decreased physical activity. This study will aim to (1) understand the way in which muscle loss occurs in PAH, particularly the role of fat surrounding the heart, and (2) look at the impact muscle loss has on quality of life, daily physical activity, and hospitalizations in patients with PAH. The findings from this study could help identify potentially treatable factors that may improve the overall quality of life and physical functioning of patients with PAH. Subjects will be asked to attend a baseline visit where the following will be performed: * Measure your vital signs * Undergo a research blood draw, less than 4 tablespoons * Provide a urine pregnancy test (if applicable) * Review demographics, personal history, and medical history * Review current PAH medications * Complete questionnaire

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent prior to initiation of any study mandated procedure. * Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification \[Humbert 2022\] * Idiopathic (IPAH) * Heritable (HPAH) * Drugs or toxins induced * Associated (APAH) with one of the following: * Connective tissue disease; * Human immunodeficiency virus (HIV) infection; * Congenital heart disease; or * Portopulmonary hypertension * Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment * Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing: * mPAP \> 20 mmHg; and * PAWP or LVEDP ≤ 15 mmHg * PVR \> 2 Wood units Exclusion Criteria: * Prior to enrollment, evidence of moderately severe obstructive ventilator defect with: * FEV1/FVC ≤ 5th percentile; and * FEV1 z-score \< -2.5 * Prior to enrollment, evidence of severe restrictive defect with * TLC \< 5th percentile * FEV1 z-score \< -4 * Prior to enrollment, hospitalization (within 1 week) for decompensated right heart failure * More than moderate aortic or mitral valve disease * LVEF \< 40% within 1 year of screening * Pregnancy
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What it tests

  • blood draw
  • Short Performance Physical Battery
  • Grip strength test
  • Six minute walk test
  • Chest CT scan
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Where

2 sites
University of Pennsylvania Hospital
Philadelphia, United States
Rhode Island Hospital
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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